WASHINGTON -- The heart has many moving parts and as humans age many of these parts wear-out or simply fail to work efficiently, and this is especially true of the valves that regulate blood flow into and out of the heart's chambers. For years, surgeons have replaced or repaired those failing valves. But about 30 percent of patients with a condition called aortic stenosis are too old or too sick for surgery, so they struggle along often disabled by chest pain as they struggle for breath.
But that may be changing. Instead of surgery, doctors can successfully implant a new valve into the heart by placing it into an artery in the groin and carefully threading up into the heart.
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Patients who received new valves this way, a technique call transcatheter aortic valve implantation or TAVI (rhymes with have-ee) had a 20 percent lower mortality rate at one year than similar patients who received only medical therapy or who had medical therapy plus a balloon that forced open the valve.
Moreover, the researchers, led by Dr. Martin B. Leon of Columbia University Medical Center/New York-Presbyterian Hospital in New York City, also found that the interventional procedure using a device called the Sapien heart-valve system reduced the combined endpoint of death from any cause or rehospitalization by almost 30 percent compared with standard treatment.
Treating just five patients would prevent one death at one year, and treating three patients would prevent one death or hospitalization.
The one negative note was the rate of stroke/major bleeding at 30 days -- 12 strokes and 30 major bleeds in the TAVI arm versus three strokes and two major bleeding events in the control group, but by one year the difference in the stroke rate was just 5 percent, which Leon said "was much better than expected."
The PARTNER trial results were scheduled for initial unveiling here Thursday at the Transcatheter Cardiovascular Therapeutics (TCT) meeting, but in an unusual move, the New England Journal of Medicine upstaged meeting organizers by publishing the results online today.
One explanation for the "impressive" mortality benefit was that the "patients in the control arm fared much worse than we had predicted. We predicted a one-year mortality of 35 percent," Dr. Michael Mack of Medical City Dallas and a co-author of the PARTNER (Placement of Aortic Transcatheter Valves) trial told MedPage Today/ABC News.
"A 50 percent mortality was much greater than anticipated, and this tells us much more about the natural history of this disease. It is much more lethal than we thought," he said.
Although the mortality results were impressive, the improvement in symptoms and function were also compelling and also favored TAVI with only 25 percent of the TAVI patients still suffering significant disability from heart failure versus almost 60 percent of the standard therapy patients.
"With patients in their 80s and 90s, the issue is often not survival but quality of life," said Dr. Robert Bonow of Northwestern University in Chicago and a past president of the American Heart Association. Bonow, who was not involved in the study, hailed the results and predicted they would advance the cause of TAVI in the United States.
"This is really a just like a plumbing problem -- you fix the broken valve, you get better flow, everything works better," Bonow explained.
The device is approved and has been in use in Europe for several years.